HyalOne is a medical device designed for patients diagnosed with osteoarthritis of the hip or knee joint.
Operation and application:
HyalOne is a sterile, non-pyrogenic, viscoelastic solution containing hyaluronic acid sodium salt, obtained by bacterial fermentation of a high molecular weight fraction. Hyaluronic acid, a polysaccharide of the glycosaminoglycan family, is a natural constituent of many human tissues such as cartilage and synovial fluid; it is constantly secreted into the joint space and is one of the basic components of the synovial fluid, which gives it a characteristic viscosity and elasticity. These features are essential for moisturizing and shock absorption, functions performed by fluid in healthy joints to protect cartilage and soft tissues from mechanical injury. In post-traumatic and degenerative joint changes in the synovial fluid, the amount of hyaluronic acid is reduced and the viscosity is lost, which results in impaired joint function and pain symptoms. Extensive data in the literature indicate that intra-articular administration of hyaluronic acid can restore the viscoelastic properties of the synovial fluid, reducing pain and improving joint mobility.
Main ingredient: sodium salt of hyaluronic acid 1.5%; Other ingredients: sodium chloride, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, water for injections. One pre-filled syringe containing 60 mg / 4 ml hyaluronic acid sodium
The product may only be administered by qualified physicians. Asepsis and injection technique must be followed. If there is effusion into the joint, it should be removed before administration. After the first administration, further treatment may be required to maintain the benefit of the treatment over a longer period of time, depending on the individual patient's needs. HyalOne must be injected using a suitable sterile needle (e.g. 18 or 20 gauge). Ultrasound-guided injections are recommended when using HyalOne in the hip joint. This is not necessary when using HyalOne in the knee joint.
Do not use the product in patients with known individual hypersensitivity to its components and in the case of infections or skin diseases in the vicinity of the injection site. There is no evidence of contraindications to repeat treatment.
The contents of the pre-filled syringe are sterile. The syringe is packed in an airtight blister. The outer surface of the pre-filled syringe in the sealed blister is not sterile, but with a higher degree of microbiological purity. Do not use if the packaging is damaged. Do not use the product after the expiry date stated on the package. The expiry date applies to the product stored in its original packaging at a temperature not exceeding 25 ° C. The product is intended for single use, which means that it can be used once and for one patient only. The assembled syringe should be discarded immediately after use, whether or not all of the solution has been administered. If the product is recycled or reused, Fidia Farmaceutici does not guarantee the efficacy, functionality, material structure, purity or sterility of the product. Reuse may cause disease, infection, or serious injury to the patient or user. After use, dispose of in accordance with local practice.
Occasionally there may be soreness, swelling, a feeling of warmth or redness at the injection site. Generally these symptoms are mild and transient. Occasionally, more severe inflammatory reactions, sometimes associated with the presence of sodium pyrophosphate crystals, have been reported following repeated intra-articular injections of hyaluronan. As with all intra-articular treatments, septic arthritis may rarely develop if general precautions are not taken or if the injection site is not decontaminated.
Contents of the package:
1 pack of HyalOne - one pre-filled syringe containing 60 mg / 4 ml of hyaluronic acid sodium salt, steam sterilized
Keep out of the reach of children, at room temperature, protected from light and moisture.
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